Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies
Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change
Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, IDEs, supplements, and technical files for CE marketing
Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions
Review and provide regulatory input on analytical and clinical study protocols
Provide support, as needed, for FDA inspections, Pre-Approval Inspections or European Notified Body Inspections
Provide guidance to pharmaceutical partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes
Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities
Support compliance activities associated with the Quality Management System to fulfill with international and domestic policies and regulations

Bachelor’s degree in a science-related area of study
Minimum of 6 years hands-on submission experience including the developing and execution of regulatory strategies for medical device and/or IVD regulated products
Must have knowledge of U.S and European product submission and registration requirements for medical devices and/or IVD regulated products
Strong understanding of product development process, design controls, and ability to effectively partner cross-functionally to develop and influence sound strategies
Ability to work independently, taking ownership for the management of processes, projects, and timelines
Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project.
Master’s degree in a science-related area of study (Preferred)
Prior experience with in vitro diagnostics (Preferred)
Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices (Preferred)
Experience leading and/or supporting US FDA submissions (Preferred)
Experience in writing/maintaining CE Technical Files (Preferred)
Ability to mentor and lead others through challenging circumstances (Preferred)

Manager – Regulatory Affairs

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